Senior Manager, Training Quality Assurance

Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated.

Kyverna is recruiting a highly motivated Manager/Sr. Manager, Training – Quality Assurance in its Technical Operations organization to help advance its mission to free patients from the siege of autoimmune disease. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why. 

The Manager/Sr. Manager, Training – QA will be responsible for the overall Learning and Development/GxP training program at Kyverna. This position will work with all Departments within Kyverna, including the Leadership Team, to ensure consistent standards and requirements for training are implemented consistently and to ensure international requirements are incorporated into the overall training program.

Responsibilities

• Oversee the overall Learning and Development/GxP training program to provide a robust, compliant, streamlined training program that supports GxP operations and can withstand the rigor of regulatory inspections.
• Manage the day-to-day activities in the electronic training management system.
• Serve as the Subject Matter Expert in the development, use, and lifecycle maintenance for the electronic training management system.
• Maintain GxP training records and files.
• Partner with functional departments to create and maintain the training matrix for all roles.
• Develop, deliver, and monitor GxP and general Quality Systems classroom training when needed (e.g. onboarding).
• Participate in Inspection readiness activities to ensure the training program is continuously inspection ready.
• Support audit and inspection activities by being the training subject matter expert. Act as subject matter expert for audit-related questions within subject matter area and beyond, including front room and back room support and management.
• Participate in internal audits as needed.
• Provide training metrics to monitor the health and effectiveness of the training program.
• Participate in Quality Management Meetings representing training program performance.
• Develop effective cross-functional relationships with functional areas and Kyverna Leadership to meet departmental and organizational goals.
• Serve as a liaison between functional departments and Quality.
• Ensure regulatory GxP requirements are implemented and maintain compliance.
• Familiarity with various training methodologies, including e-learning, classroom training, on-the-job training, and blended learning approaches.
• Other duties as assigned.

Requirements

• Bachelor’s degree in science or engineering discipline with +7 years experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry OR
• Master’s degree with +4 years experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry.
• Experience working in a regulated environment (cGMP/GCP/GTP) in a training role essential.
• Experience working with electronic training/learning management systems required.
• Experience creating/developing/administering SCORM or other electronic training content preferred.
• Strong knowledge of applicable regulations and standards related to Cell Therapies, Cell Collection, and Donor Requirements.
• Previous experience in designing, delivering, and evaluating training programs.
• Proficiency in designing and developing training programs, curriculums, courses, and materials that effectively convey complex scientific and technical information.
• Independently motivated, detail oriented and good problem-solving ability.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
• Excellent verbal, written and presentation skills and effectively communicate with all levels of management.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
• Self-starter, works effectively in teams.

The salary range for this position is $165,000 USD to $180,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.

(Position is commensurate with the experience of the successful candidate.)

Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets